Process Engineer - Vulcan

BioHorizons; Hoover (AL); Hybrid; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical plans

HSA/FSA

Dental insurance

Wellness program

401(k) with matching

Generous PTO

Disability insurance

Life insurance

Casual dress code

Job summary

BioHorizons seeks a Vulcan Process Engineer in Hoover, AL to drive manufacturing improvements and sustain compliant production. You will collaborate with cross-functional teams and management to optimize processes, support new product introductions, and ensure audit readiness in a regulated environment.

The role requires a Bachelor's in engineering, 4+ years in FDA/ISO medical device manufacturing, and hands-on Lean/Six Sigma, root-cause analysis, and project leadership.

Qualifications

• Bachelor’s degree in engineering or related field.
• 4+ years’ experience in FDA/ISO regulated medical device manufacturing.
• Minimum 2 years' experience with medical device workflows.
• Experience facilitating cross-functional teams; root-cause analysis, data collection, and problem solving.

Responsibilities

• Drive improvement projects and coordinate cross-functional efforts to achieve project success.
• Identify challenge areas and gaps for process improvement/waste reduction.
• Use Lean and Six Sigma techniques to eliminate process waste.
• Develop, evaluate, and improve manufacturing processes for existing and new products.
• Support engineering initiatives in analyzing production processes for repeatability and efficiency.
• Contribute process knowledge to process validation (IQ, OQ, PQ).
• Generate and maintain SOPs for updated or new processes.
• Assist in audits and ensure audit readiness; support first-, second-, and third-party audits.
• Communicate project statuses and updates with the team.
• Facilitate training for process changes with management.
• Onboard new products with Vulcan management and other departments.
• Develop and analyze KPIs for process evaluation and forecasting for growth and capacity planning.

Skills

Communication skills

Attention to detail

Initiative

Planning and organization

Project management

Initiative and accountability

Cross-functional collaboration

Education

Bachelor’s degree in engineering

Job description

The Vulcan Process Engineerinfluences the company’s direction with respect to production. This position works with all departments and Vulcan management to evaluate current processes with respect to continuous improvement to keep production running smoothly. Works with Vulcan managers/supervisors to optimize organizational business performance by maintaining compliance with domestic quality system regulations.

This position is onsite based in Hoover, AL and is not open to remote work.

We are interested in every qualified candidate who is eligible to work in the United States. However, we are not able to sponsor visas.

Essential Duties and Responsibilities:

• Responsible for driving improvement projects and coordinating efforts between a cross-functional team, with both internal and external stakeholders to achieve project success.
• Works with management to identify challenge areas and key gaps within organization for process improvement/ waste reduction projects.
• Utilize Lean and Six Sigma techniques to identify and eliminate process waste throughout the system.
• Develop, evaluate, and improve manufacturing processes for existing and new products.
• Support Engineering initiatives in analyzing the production process for repeatability and efficiency.
• Contributes process knowledge to developing and executing process validation efforts (IQ, OQ, PQ).
• Generate and maintain SOPs as needed for updated or new processes.
• Help to maintain audit readiness and assist in first-party, second-party and third-party audits.
• Communicate statuses and updates with team for all assigned projects.
• Works with management team to facilitate training for process changes.
• Works with all departments and Vulcan management to facilitate the onboarding of new products.
• Develop, analyze, and maintain key performance indicators for process evaluation.
• Develop and analyze forecasting to predict growth and capacity planning.

Qualifications:

• Effective communication and facilitation skills required.
• Strong detail on detail and accuracy.
• High degree of initiative and self-motivation with a strong sense of accountability.
• Outstanding planning and organizational skills and techniques required.
• Ability to plan and manage complex and successful projects; understand available resources, develop a timeline, budget and assign areas of responsibility.

Education and/or Experience:

• Bachelor’s degree in an engineering-related field and/or an equivalent combination of education/experience
• 4+ years’ experience working at an FDA and/or ISO regulated medical device manufacturer.
• Minimum of 2 years' experience working with medical device workflows.
• Experience in facilitating cross-functional teams; overseeing root-cause analysis, data collection, and problem solving.
• 2 comprehensive medical plan options to choose from available the first of each month following your date of hire
• Flexible Spending Account or HSA Account available
• Company paid Dental Insurance for employee and dependents
• Wellness Plan
• 401k with 5% matching
• Generous PTO plan including 11 paid holidays, 2 Floating Holidays and Community Service Hours
• Company paid Short Term Disability
• Long Term Disability
• Company provided Life Insurance
• Casual Dress Code
• Social events for employees and family

Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Please note that any offer of employment made by BioHorizons is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen.